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BioZ - study Biologics during pregnancy Immune profiling of peripheral and endometrial immune cells of women with psoriasis treated with biologics

BioZ - study Biologics during pregnancy Immune profiling of peripheral and endometrial immune cells of women with psoriasis treated with biologics - BioZ

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57075
Enrollment
80
Registered
2024-10-31
Start date
2025-06-27
Completion date
Unknown
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

plaque psoriasis psoriasis

Interventions

n.v.t.

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Patients: In order to be eligible to participate in this study, a patient must meet all  of the following criteria: - Women aged 18-45 year - Diagnosis of psoriasis - Using adalimumab, certolizumab, ustekinumab, ixekizumab, guselkumab or methotrexate for at  least 6 months, or topical treatment.  Healthy controls: In order to be eligible to participate in this study, a healthy control must  meet the following criteria: - Women aged 18-45 year.

Exclusion criteria

Exclusion criteria: Patients:  A potential patient who meets any of the following criteria will be excluded  from participation in this study: - Use of other birth control than oral contraceptives (i.e., (copper)  intra-uterine devices (IUD)) - Immune mediated co-morbidities (e.g., inflammatory bowel disease, rheumatoid  arthritis) or diabetes mellitus - Smoking - Participants who are not capable of signing the informed consent  Only for patients treated with biologics the following is also applicable: - Primary indication of biologic is not psoriasis.  - Use of other immunomodulating medication, such as methotrexate, or  antidepressants.  Only for patients treated with methotrexate the following is also applicable: - Primary indication of methotrexate is not psoriasis.  - Use of other immunomodulating medication, such as biologics, or  antidepressants.  Only for patients with topical treatment the following is also applicable: - Use of any systemic medication that is prescribed for psoriasis, such as  biologics or methotrexate, or antidepressants.  Healthy controls:  A potential healthy control who meets any of the following criteria will be  excluded from participation in this study: - Use of other birth control than oral contraceptives (i.e., copper  intra-uterine device (IUD)) - Use of immunomodulating medication or antidepressants - Diagnosed with an autoimmune disease or diabetes mellitus - Known disorder of reproduction  - Smoking - Participants who are not capable of signing the informed consent. 

Design outcomes

Primary

MeasureTime frame
Differences in phenotype and function of immune cells present in the menstrual blood between patients with psoriasis using biologics, patients with psoriasis using methotrexate, patients with psoriasis using only topical medication and healthy controls.

Countries

Netherlands

Contacts

Public ContactJMPA van den Reek

Radboud Universitair Medisch Centrum

onderzoek.derma@radboudumc.nl(024) 3613724

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)